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With just over a month until new FDA regulations take effect mandating that all electronically submitted application data conform to a standardized format, the organization responsible for setting those standards is working to train industry to meet the requirements, and is considering developing more frequent and granular updates to those standards in the future. Read More
FDA reviewers expressed strong concerns over the possibility of liver damage related to solithromycin treatment ahead of an advisory committee meeting Friday on whether the drug should be approved as an antibiotic for community-acquired bacterial pneumonia. Read More